Germantown-based Senseonics Holdings, Inc. announced the U.S. Food and Drug Administration has approved its Premarket Approval application to market the company's Eversense Continuous Glucose Monitoring System to people with diabetes in the United States. The system is the first and only Continuous Glucose Monitoring System to feature an implantable glucose sensor and provide long-term continuous monitoring for up to three months.
The technology relies on a small device that’s implanted under the skin of the upper arm. A transmitter is stuck to the skin over the spot where the implant is located, which relies on fluorescence to determine the readings measured by the implant. The transmitter then sends the data, via Bluetooth, to a paired smartphone or smartwatch, which keeps tabs on the patient’s historical blood glucose trends.
"We're very pleased to receive this FDA approval that allows us to make Eversense available in the United States, as it is in many European markets. With the parallel trends of wearable personal devices and medical implantables for people to manage their health, this product exemplifies the natural evolution for diabetes devices, and Senseonics is excited to help lead the way," said Tim Goodnow, President and CEO of Senseonics. "More importantly, we believe the unique features Eversense offers will help open up CGM to millions of people with diabetes who, up to this point, have been hesitant to try CGM despite the clear health benefits it provides."
Earlier this month, on August 7, the company announced that the Eversense CGM System was available at trained clinics across the U.S. and physicians have begun sensor placements with patients. Concurrently, the company reported that its first commercial payer, Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, has added coverage of the Eversense System to its Medical Policy.
These announcements mark the company’s rapid entry into the U.S. commercial market, with the product available to U.S. patients just six weeks since the FDA approval of the product in late June.
“Since receiving FDA approval for the Eversense System, we have experienced tremendous support and interest from physicians and their patients,” said Goodnow. “We are thrilled that clinics and users can now benefit from Eversense, and we’re also pleased to receive our first medical policy coverage, clearing the way so more people with diabetes can access this important tool for helping ease the burden of managing diabetes.”
Product shipments began the last week of July to diabetes clinics across the United States. Physicians and staff have been subsequently trained and authorized on the Eversense System and have started their first patients on the system.
“Research has repeatedly demonstrated the clinical benefits patients experience with regular CGM use, including improved glucose control and protection against severe hypoglycemia,” said Steven Edelman, MD, Professor of Medicine at University of California San Diego, Founder & Director of Taking Control of Your Diabetes, and Senseonics Board member. “Despite these benefits, a significant number of people with diabetes do not use, or have access to, continuous glucose monitoring. Furthermore, the data shows that many people who’ve tried traditional CGM in the past either don’t wear it as often as they should or don’t stick with it for a variety of reasons, including concerns surrounding sensor accuracy, sensor insertion, and sensor discomfort. So, it’s important that patients have choices and that medical device companies continue to advance the field of CGM with innovations that make it easier for the end user.”
The Eversense System's application was based on the previously-reported results of a trial in which Eversense was studied in 90 adults with type 1 or type 2 diabetes at eight clinical centers in the United States. The study demonstrated the system's safety and effectiveness over 90 days of continuous glucose sensor wear. This March, the FDA's Clinical Chemistry and Clinical Toxicology Devices Panel of independent medical experts voted unanimously, 8 to 0, that the system not only was safe and effective, but also that its benefits outweighed the risks.
Patients who are interested in getting started on Eversense can sign up at www.eversensediabetes.com/get-started-today. Physicians interested in becoming an authorized practice can contact 844-SENSE4U (844-736-7348).
Photos courtesy Sensonics Holdings Inc.